Acute DVT of Lower ExtremityEarly Phase 1NCT06145269
Recanalization Rate of Acute DVT
A Early Phase 1 study testing New oral anticoagulant (rivaroxaban) and Marevan (warfarin) in people with Acute DVT of Lower Extremity, run by Assiut University.
Trial summary
Rporting and evaluation of the rate of recanalization of acute DVT of the lower limb at one year follow-up comparing the results of using NOACs vs. conventional treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute DVT of Lower Extremity
- What is being tested?
- New oral anticoagulant (rivaroxaban) and Marevan (warfarin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Jun 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients suffering from first attack of acute DVT (De novo) of the lower limb who (only femoral-popliteal type) aged 18 - 80 years.
Who cannot join
- Patients suffering from recurrent DVT.
- Patients with acute DVT candidate for CDT (limb threatening acute DVT).
- Patients suffering from acute DVT with malignancy.
- Pregnant and Lactating females.
- Patients with severe renal Impairment (CrCl <30mL/min), Severe hepatic impairment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Recanalization Rate of Acute Deep Venous Thrombosis Related to Therapeutic Modality- Comparative Study; New Oral Anticoagulants (NOACs) Vs. Conventional Treatment.
Rporting and evaluation of the rate of recanalization of acute DVT of the lower limb at one year follow-up comparing the results of using NOACs vs. conventional treatment.
Read the detailed description
Deep vein thrombosis (DVT) is an important cause of disability and mortality in our society . The incidence of DVT significantly increases with age, being more prevalent in women than men . The location of DVT is also an important factor to be studied because of its association with pulmonary embolism and development of post-thrombotic syndrome (PTS) , Currently, duplex ultrasound scanning (DUS) is the method of choice for diagnosis of DVT because it is non-invasive, provides real-time imaging, and has high sensitivity and specificity especially for detection of proximal DVT .
The new oral anticoagulants (NOACs), are poised to replace warfarin for treatment of the majority of patients with venous thromboembolism (VTE), With a rapid onset of action and the capacity to be administered in fixed doses without routine coagulation monitoring, NOACs have been shown to be noninferior to conventional anticoagulant therapy for prevention of recurrence with less bleeding.
Most studies have reported that more advantages than disadvantages for NOACs when compared with VKAs, with the most important advantages of NOACs including safety issues (ie, a lower incidence of major bleeding), convenience of use, minor drug and food interactions, a wide therapeutic window, and no need for laboratory monitoring. Nonetheless, there are some conditions for which VKAs remain the drug of choice.
- Conditions
- Acute DVT of Lower Extremity
- Being tested
- New oral anticoagulant (rivaroxaban) and Marevan (warfarin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New oral anticoagulant (rivaroxaban) and Marevan (warfarin)Drug
comparison between 2 drug, (rivaroxaban) and Marevan (warfarin)
| Study group | Role | What they receive |
|---|---|---|
| New oral anticoagulant (rivaroxaban) | Active comparator | We will use (rivaroxaban) 15 mg oral tablets twice a day, After 21 days: Should transition to 20 mg orally once a day untill we complete 6 months from the starting the treatment. Receives: Drug: New oral anticoagulant (rivaroxaban) and Marevan (warfarin) |
| Marevan (warfarin) | Active comparator | Initiate warfarin on day 1 or 2 of parenteral anticoagulation therapy (eg, LMWH or unfractionated heparin) Overlap warfarin and parenteral anticoagulant for at least 5 days until desired INR (>2.0) maintained for 24 hours, then discontinue parenteral therapy and continue only with (warfarin) tablets 5 mg/day for 6 months. Receives: Drug: New oral anticoagulant (rivaroxaban) and Marevan (warfarin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recanalization rate of the thrombosed vein with the two comparable groups.
Reporting and evaluation the rate of recanalization of acute DVT of the lower limb at one year follow-up comparing the results of using NOACs vs. conventional treatment.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DVT of Lower ExtremityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mahmoud Yaseen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145269
- Sponsor's protocol ID
- Recanalization rate(acute DVT)
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recanalization Rate of Acute Deep Venous Thrombosis Related to Therapeutic Modality- Comparative Study; New Oral Anticoagulants (NOACs) Vs. Conventional Treatment.
- ClinicalTrials.gov ID
- NCT06145269
- Acronym / sponsor ID
- Recanalization rate(acute DVT)
- Conditions
- Acute DVT of Lower Extremity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rporting and evaluation of the rate of recanalization of acute DVT of the lower limb at one year follow-up comparing the results of using NOACs vs. conventional treatment.
Detailed description
Deep vein thrombosis (DVT) is an important cause of disability and mortality in our society . The incidence of DVT significantly increases with age, being more prevalent in women than men . The location of DVT is also an important factor to be studied because of its association with pulmonary embolism and development of post-thrombotic syndrome (PTS) , Currently, duplex ultrasound scanning (DUS) is the method of choice for diagnosis of DVT because it is non-invasive, provides real-time imaging, and has high sensitivity and specificity especially for detection of proximal DVT .
The new oral anticoagulants (NOACs), are poised to replace warfarin for treatment of the majority of patients with venous thromboembolism (VTE), With a rapid onset of action and the capacity to be administered in fixed doses without routine coagulation monitoring, NOACs have been shown to be noninferior to conventional anticoagulant therapy for prevention of recurrence with less bleeding.
Most studies have reported that more advantages than disadvantages for NOACs when compared with VKAs, with the most important advantages of NOACs including safety issues (ie, a lower incidence of major bleeding), convenience of use, minor drug and food interactions, a wide therapeutic window, and no need for laboratory monitoring. Nonetheless, there are some conditions for which VKAs remain the drug of choice.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New oral anticoagulant (rivaroxaban) | Active comparator | Drug: New oral anticoagulant (rivaroxaban) and Marevan (warfarin)We will use (rivaroxaban) 15 mg oral tablets twice a day, After 21 days: Should transition to 20 mg orally once a day untill we complete 6 months from the starting the treatment. |
| Marevan (warfarin) | Active comparator | Drug: New oral anticoagulant (rivaroxaban) and Marevan (warfarin)Initiate warfarin on day 1 or 2 of parenteral anticoagulation therapy (eg, LMWH or unfractionated heparin) Overlap warfarin and parenteral anticoagulant for at least 5 days until desired INR (>2.0) maintained for 24 hours, then discontinue parenteral therapy and continue only with (warfarin) tablets 5 mg/day for 6 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Patients suffering from first attack of acute DVT (De novo) of the lower limb who (only femoral-popliteal type) aged 18 - 80 years.
Key exclusion criteria (5 listed)
- Patients suffering from recurrent DVT.
- Patients with acute DVT candidate for CDT (limb threatening acute DVT).
- Patients suffering from acute DVT with malignancy.
- Pregnant and Lactating females.
- Patients with severe renal Impairment (CrCl <30mL/min), Severe hepatic impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New oral anticoagulant (rivaroxaban) and Marevan (warfarin)comparison between 2 drug, (rivaroxaban) and Marevan (warfarin) | Drug | Marevan (warfarin), New oral anticoagulant (rivaroxaban) |
Primary outcome
Recanalization rate of the thrombosed vein with the two comparable groups.
Time frame: baseline
Reporting and evaluation the rate of recanalization of acute DVT of the lower limb at one year follow-up comparing the results of using NOACs vs. conventional treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- INCIDENCE OF DEEP VENOUS THROMBOSIS IN STROKE PATIENTS IN MEDICAL INTENSIVE CARE UNIT ZAGAZIG UNIVERSITY HOSPITALS, EGYPTLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing New oral anticoagulant (rivaroxaban) and Marevan (warfarin) in people with Acute DVT of Lower Extremity, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr Yaseen, bachelor (01020398137 ext. +2, amryaseen1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recanalization rate of the thrombosed vein with the two comparable groups. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.